NCT03047057

Brief Summary

Radical cystectomy (RC) remains the gold standard for treatment of patients with muscle invasive bladder cancer, or recurrent high grade non-muscle invasive bladder cancer. Nowadays, enhanced recovery pathway is used to decrease morbidity and improve acute rehabilitation after RC. Postoperative ileus is the most frequent reason for prolonged hospital stay following cystectomy.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
57

participants targeted

Target at P25-P50 for phase_2

Timeline
Completed

Started Mar 2017

Shorter than P25 for phase_2

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

February 6, 2017

Completed
2 days until next milestone

First Posted

Study publicly available on registry

February 8, 2017

Completed
23 days until next milestone

Study Start

First participant enrolled

March 3, 2017

Completed
1.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 20, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 20, 2018

Completed
Last Updated

August 7, 2018

Status Verified

August 1, 2018

Enrollment Period

1.4 years

First QC Date

February 6, 2017

Last Update Submit

August 6, 2018

Conditions

Postoperative Ileus

Outcome Measures

Primary Outcomes (1)

  • Postoperative return of gastrointestinal (GI) function

    Time to the first defecation

    15 day

Secondary Outcomes (1)

  • Postoperative Pain

    72 hours after surgery

Study Arms (2)

Lidocaine

EXPERIMENTAL

IV Lidocaine infusion

Drug: Lidocaine

Control

PLACEBO COMPARATOR

IV normal saline infusion

Drug: IV normal saline

Interventions

LidocaineDRUG

IV Lidocaine infusion

Lidocaine
IV normal salineDRUG

IV normal saline infusion

Also known as: normal saline
Control

Eligibility Criteria

Age45 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • yr ASA class I,II, and III Elective radical cystectomy

You may not qualify if:

  • Allergy to the study medication, pre-existing chronic pain at any site requiring treatment, Psychiatric disease, hepatic or renal impairment, seizure disorder requiring medication within the previous 2 years

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Seham Mohamed Moeen Ibrahim

Asyut, 71111, Egypt

Location

Related Publications (1)

  • Moeen SM, Moeen AM. Usage of Intravenous Lidocaine Infusion with Enhanced Recovery Pathway in Patients Scheduled for Open Radical Cystectomy: A Randomized Trial. Pain Physician. 2019 Mar;22(2):E71-E80.

    PMID: 30921979DERIVED

MeSH Terms

Interventions

LidocaineSaline Solution

Intervention Hierarchy (Ancestors)

AcetanilidesAnilidesAmidesOrganic ChemicalsAniline CompoundsAminesCrystalloid SolutionsIsotonic SolutionsSolutionsPharmaceutical Preparations

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
lecturer

Study Record Dates

First Submitted

February 6, 2017

First Posted

February 8, 2017

Study Start

March 3, 2017

Primary Completion

July 20, 2018

Study Completion

July 20, 2018

Last Updated

August 7, 2018

Record last verified: 2018-08

Data Sharing

IPD Sharing
Will not share

Locations

EG(1)